# K091681: Finess Sinus Treatment System (Access Sheath Component)

- Pathway: 510(k) (Special)
- Applicant: Entellus Medical, Inc.
- Decided: Jul 8, 2009 after 28 days
- Product code: LRC (Instrument, Ent Manual Surgical)
- Device class: 1
- Regulation: 21 CFR 874.4420
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K073202: Ardis Spacer, Abbott Spine, Inc. (2008). Our reading of the summary gave K073202, FDA’s number for Ardis Spacer (Abbott Spine, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “FinESS Sinus Treatment”. Kept off the family tree. Summary page 1.

## Indications for use
FinESS is indicated to access and treat the maxillary sinus ostium and the ethmoid infundibulum in adults with a trans-antral approach. The bony sinus outflow tract is remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

Source page: https://510kreport.com/device/K091681
Methodology: https://510kreport.com/methodology